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Behavioural Intervention

Digital Therapeutic for Depression After Traumatic Brain Injury

N/A
Recruiting
Led By David Brody, MD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be aged ≥ 18 to ≤ 65 years
Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 16 compared to baseline
Awards & highlights

Study Summary

This trial will assess the efficacy of a cognitive-behavioral therapy mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury, compared to an educational comparison mobile application.

Who is the study for?
This trial is for current and former US military personnel aged 18-65 who have had a mild traumatic brain injury (mTBI) and are experiencing mild to moderate depression. Participants must own or have access to a smartphone with internet, be able to consent, and maintain regular mental health care. Those on new depression treatments or with recent medication changes, psychotic/bipolar symptoms, safety concerns, or active suicidal/homicidal plans cannot join.Check my eligibility
What is being tested?
The study is testing a mobile app that uses cognitive-behavioral therapy (CBT) designed for those with mTBI-related depression against an educational app. The goal is to see if the CBT-based digital therapeutic can help reduce depressive symptoms more effectively than just receiving psychoeducational content.See study design
What are the potential side effects?
Since this trial involves digital therapeutics via an app rather than medication, traditional side effects like you'd expect from drugs aren't applicable. However, users may experience discomfort or emotional distress when engaging in psychological therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with a mild traumatic brain injury according to VA and DoD standards.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 16, compared to baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 16, compared to baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who complete all treatment modules compared to those who do not
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report family history of depression compared to those who do no
+2 more
Secondary outcome measures
Blinding Efficacy
Change in Credibility and Expectancy Questionnaire (CEQ)
Change of the mean difference in Insomnia Severity Index (ISI) total score
+2 more
Other outcome measures
HEXACO Personality Inventory-Revised (HEXACO-PI-R)
Mobile Agnew Relationship Measure (mARM) Questionnaire
User Version of the Mobile Application Rating Scale (uMARS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CBT DTxExperimental Treatment1 Intervention
Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.
Group II: Psychoeducations DTxActive Control1 Intervention
Participants randomized to the comparison group will access an unstructured educational DTx.

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,509 Total Patients Enrolled
David Brody, MDPrincipal InvestigatorUniformed Services University of the Health Sciences

Media Library

Concussion Research Study Groups: CBT DTx, Psychoeducations DTx

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there the possibility for me to join in this research effort?

"Suitable candidates for this project must be 18 years old or above and below the age of 65, with a diagnosis of mental depression. The trial is seeking to enroll 200 participants in total."

Answered by AI

Is the study open to individuals younger than sixty years of age?

"This clinical trial is limited to people aged 18-65. There are 342 trials for those under the age of 18 and 1544 studies specifically targeting participants over 65 years old."

Answered by AI

What are the fundamental goals of this medical experiment?

"This study aims to analyse the difference in patient health questionnaire (PHQ-9) scores from baseline over a twelve week period, with secondary objectives focused on evaluating credibility and expectancy questionnaires (CEQ), insomnia severities indices (ISI), and posttraumatic stress disorder checklists (PCL-5)."

Answered by AI

How many study participants have been accepted into this research endeavor?

"Absolutely. According to clinicaltrials.gov, this research is in the process of recruiting participants and was first posted on June 22nd 2022. The study's most recent update occurred on September 28th 2022 with 200 people sought from a single medical centre."

Answered by AI

Are there any open slots remaining for participation in this research?

"Affirmative. According to the information published on clinicaltrials.gov, this medical experiment is actively recruiting 200 patients at a single site. The study was first posted on June 22nd 2022 and has been updated most recently on September 28th 2022."

Answered by AI
~25 spots leftby Oct 2024